8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HORIZON REGULAR ETCHING GEL
FDA 510(k)
FDA Class 1
·Dental
TROJAN-ENZ LATEX CONDOMS W/SPERMICIDAL MODIFIED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LASAG MICRORUPTER 2 ND:YAG LASER TRABECULOPLASTY
FDA 510(k)
FDA Class 2
·Ophthalmic
PROCEDURE TYPE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: THERE WAS POSTOPERATI
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO·Product code GDW·June 2, 2014
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·January 9, 2013
ASR 300
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·November 14, 2010
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025